Planning As Tool For Effective QMS

Definition

Systematic process that translates quality policy into measurable objectives and requirements, and lays down a sequence of steps for realizing them within a specified timeframe.

Companies want to produce quality work that they're happy with and customers can appreciate. One way to do so is a process known as quality planning. Come along as we learn what quality planning is, the process, and what tools are valuable in the ISO 9001 certification,

Quality Planning Defined

Meet Molly. Molly just found out that she will be the new leader for an upcoming project. Because this is her first project, she decides to do some research on how to effectively lead a project. The first place she starts is by determining the most important aspects of the project; essentially, she is determining which standards are necessary in order to successfully complete the project. Molly learns that she needs to identify what standards are relevant to the project and how she and her team will meet them. This is known as quality planning and is the focus of this lesson.

Quality planning is the task of determining what factors are important to a project and figuring out how to meet those factors. Such factors often include the resources that will be used, the steps needed to complete the project and any other specifications. So for Molly, this means she needs to plan what resources the project will need, determine the cost of those resources, plan a timeline for completing the project, outline the steps she and her team will take, and she will need to assign the tasks and responsibilities to each person.

 Process

“Quality planning,” as used here, is a structured process for developing products (both goods and services) that ensures that customer needs are met by the final result. The tools and methods of quality planning are incorporated along with the technological tools for the particular product being developed and delivered. Designing a new automobile requires automotive engineering and related disciplines, developing an effective care path for juvenile diabetes will draw on the expert methods of specialized physicians, and planning a new approach for guest services at a resort will require the techniques of an experienced hotelier. All three need the process, methods, tools, and techniques of quality planning to ensure that the final designs for the automobile, diabetic care, and resort services not only fulfill the best technical requirements of the relevant disciplines but also meet the needs of the customers who will purchase and benefit from the products.

The Quality Planning Problem

The quality planning process and its associated methods, tools, and techniques have been developed Because in the history of modern society, organizations have rather universally demonstrated a consistent failure to produce the goods and services that unerringly delight their customers. As a customer, everyone has been dismayed time and time again when flights are delayed, radioactive contamination spreads, medical treatment is not consistent with best practices, a child’s toy fails to function, a new piece of software is not as fast or user-friendly as anticipated, government responds with glacial speed (if at all), or a home washing machine with the latest high-tech gadget delivers at higher cost clothes that are no cleaner than before. These frequent, large quality gaps are really the compound result of a number of smaller gaps illustrated in Figure 3.1. The first component of the quality gap is the understanding gap, that is, lack of understanding of what the customer needs. Sometimes this gap opens up because the producer simply fails to consider who the customers are and what they need. More often the gap is there because the supplying organization has erroneous confidence in its ability to understand exactly what the customer really needs. The final perception gap in Figure 3.1 also arises from a failure to understand the customer and the customer needs. Customers do not experience a new suit of clothes or the continuity in service from a local utility simply based on the technical merits of the product. Customers react to how they perceive the good or service provides them with a benefit.

3.2 SECTION THREE

The second constituent of the quality gap is a design gap. Even if there were perfect knowledge about customer needs and perceptions, many organizations would fail to create designs for their goods and services that are fully consistent with that understanding. Some of this failure arises from the fact that the people who understand customers and the disciplines they use for understanding customer needs are often systematically isolated from those who actually create the designs. In addition, designers—whether they design sophisticated equipment or delicate human services—often lack the simple tools that would enable them to combine their technical expertise with an understanding of the customer needs to create a truly superior product. The third gap is the process gap. Many splendid designs fail because the process by which the physical product is created or the service is delivered is not capable of conforming to the design consistently time after time. This lack of process capability is one of the most persistent and bedevilling failures in the total quality gap. The fourth gap is the operations gap. The means by which the process is operated and controlled may create additional deficiencies in the delivery of the final good or service. ISO 9001 consultants can provide cost effective guidance and play an important role in the quality management System

Role of HRM in effective implementation of QMS

When a business organization  lacks  in  the human resources with  correct  attitude and capability for  designing and operating the business processes that fulfill the customer expectations, the QMS may fail to deliver any tangible results.  This is the reason, why ISO 9001 :2015  has   the HRM principles embedded in the  basic structure.  People oriented philosophy is apparent in the following  quality management  principles: 

• QMP2   principle of leadership,
• QMP 3  principle  of people  engagement
• QMP 7 principle of relationship management

The international  standard gives a lot of importance to the human aspect of an organization. Enthusiastic  teams  of  trained  and motivated employees can ensure that the company  achieves business purpose and  QMS objectives by supporting the system whole heartedly.

HRM functions include

• defining the organization structure,  authority and  responsibilities of the employee roles,
• clear communication of these roles  and job descriptions to employees,
• determining skills and abilities(competence, experience , education ) needed for each role,
• evaluating competence of employees and building competence through training,
• evaluating the effectiveness of training
• managing performance and compensation to motivate the workforce and
• enhancing employee engagement .

Detailed  HRM requirements of  ISO 9001 certification

Planning for  ISO 9001 certification should be done with active  involvement of HR professionals as well as ISO 9001 consultants. Detailed clauses affecting  HRM are mentioned below. 

ISO 9001:2015, in clause 4.4 d requires resources (including human resources) needed  for the business  processes be determined. Clause 4.4e requires  that authorities and responsibilities be assigned for all processes in a very clear manner.

Clause 5.1.1 states that  the top management of the enterprise must  display leadership with commitment by

1. accepting  accountability for  maintaining effectiveness of the QMS,

      b. making sure that  quality policy is established along with quality objectives, (quality policy must be fully aligned to strategic direction and  business environment( context)

c.  communicating quality policy to  ensure understanding  and application

d  integrating   QMS into enterprise  processes

e creating  employee awareness in favor of  process approach

f providing  resources for  QMS including human resources

g promoting  employee awareness of total quality management  and need for conformity to QMS requirements

h achieving business results through effectiveness of QMS

I motivating, directing, engaging  and supporting  all people to contribute to QMS effectiveness  

J  supporting and promoting  improvement throughout the enterprise

K   providing   support to different  management  roles for leadership  in areas of  their  responsibility towards QMS

Delegating authority and responsibility for QMS

Clause 5.3 stipulates that authorities as well as responsibilities for  roles relevant to QMS must be clearly assigned, with clear communication for understanding. This delegation is for

A.  ensuring conformity to requirements

B.  making enterprise QMS processes to deliver  intended outputs

C.  reporting to top management about QMS performance and  need for changes as well as improvements

D. making sure that customer focus is promoted

E. maintaining integrity  during managing  changes for the system.

6.2.2 c requires  determination of  who will achieve objectives.

6.3 c says that while planning changes,   management  should ensure availability of  resources( human as well as others) and (6.3d )consider  changes in responsibility authority to make changes fruitful.

Requirement of competence

7.2a. requires that the competence requirement of persons affecting quality performance of the organization must be determined

7.2b. requires that management make sure (by collecting information) that  people are competent ( through experience, training as well as  education)

How to maintain your ISO certification after certification

Implementing ISO systems is an easy task with a help of an ISO consultant and once the certification is passed successfully, it might appear that the biggest part of the job is done. But, don’t rest on your laurels for long because the real job with your Business Management System is about to start. Once you start maintaining the Business Management System, you will see that passing the certification is not a problem or stressful if all activities required by the standard are performed.

Very often, companies are not sure what needs to be done prior to the surveillance audit, and therefore don’t gather the necessary information or perform the required activities. This usually results in calling the consultant to make a fix and help them formally pass the certification audit. This is only a quick fix and doesn’t really bring the company any value except having the certificate for formally complying with the standard. But, after having the certificate for several years and harvesting no real benefits for the company, people start wondering how to put their  Business Management system to work.

Go from Plan to Do phase with help from an ISO consultant

Developing procedures is easier than implementing them. Ensuring that the procedures are followed takes more time than writing them. Once the procedures are written, it will take some time to train employees to follow them. Of course, the majority of the activities were already performed even without the standard, but those new ones need time to be adopted by the employees. That is why it is important to raise awareness of the process owners first in order to ensure that they will enforce the procedures among the employees.

This will definitely require filling in some additional records and keeping track of activities, but in the end, you will have more data to analyze during the management review and this will help you make decisions based on facts rather than assumptions.

Training provided by ISO consultants

As mentioned above, the new activities will definitely require additional training of employees. Specialist ISO consultants like Anitech are able provide training to your staff on your system instead wasting time on a generic system. The good thing is that the standard provides the organization with the framework on how to identify the needs and plan the training along with the requirements to measure training effectiveness. The systematic approach to competence will help the organization not only to achieve it regarding the standard requirements, but also for other processes as well. Also, measuring training effectiveness will provide you with information on how people are really competent instead of just collecting certificates.

Control of outsourcing partners and suppliers

This may seem like reinventing the wheel, but there are not many companies that have a structured approach to this topic. In most cases they rely on gut feeling and price, but these aren’t the only criteria for deciding which supplier to hire or which  supplier use again. Sometimes it is good to stop for a second and define what you really expect from your supplier, and if it is already transformed into the procedure, you only need to evaluate the suppliers at planned intervals. Some of them left a good impression a few years ago, but are they still up to the task?

Monitoring and measuring

Monitoring and measuring should provide you with information on the status of a system, process, or activities within your Business Management System. If you set up the monitoring and measuring process correctly, it will provide you with information about the performance of your processes. If not, this is something that needs to be considered during the next management review.

Customer satisfaction

Being one of the most important principles behind ISO based management system, customer focus is demonstrated through monitoring and measuring customer satisfaction. The company must define how and how often it will conduct surveys to determine customer perception of your service / product Having relevant information on how the customers perceive the organization is a valuable input for further development of the products and services and the company itself.

Check and Act phases

Gathering relevant information about the system through monitoring and measuring and following the process procedures will enable top management to exercise the last principle of ISO based management system, and that is evidence-based decision making. A detailed and thorough audit conducted by specialist ISO consultants will provide you with additional information not only about the level of compliance, but also about the condition of your entire system. Together with other information gathered along the way, the top management will be able to conduct good, value-added management review and make decisions that lead to continual improvement of the system and the company.

External audit without stress

Having all these elements of the system in place means having an effective Business Management System, the one that really adds value to your organisation.Having an simple to use system will assist an organisation to breeze through an ISO certification audit.

Quality Management System:How Total Quality Management Can Be Applied to Maintenance System

Maintenance systems all over the world   aim at high reliability and availability of equipment and other assets. Other objectives of maintenance systems include:

• ·         Reduction in production loss (due to unplanned stoppages)
• ·         Extended productive life of assets
• ·         Higher resale value
• ·         Safety
• ·         Lower cycletime of diagnosing the equipment  failures and repairing and restoring equipment to health
•       Avoiding surprises
• ·         Higher productivity  and efficiency of equipment
• ·         Reduced setup delay and  losses  due to lowspeed operation of machines
• ·         Lower overall operational expenses, inclusive of cost of maintenance.
• ·         Reducing the loss due to catastrophic failure of equipment

Relevance of TQM in maintenance

Total quality management (TQM) has been applied successfully for maintenance systems, in order to improve its effectiveness. The concept of TQM has an interesting history.

At the end of the Second World War, in order to minimize delivery of defectives to customers, producers began to emphasize stringent norms for finished goods inspection. However this caused a rise in rejection rate and cost of goods  increased.

In order to reduce the production of defectives, producers began to improve quality at the manufacturing stage. The success was limited, because experience told them that many defects were caused not due to manufacturing stage, but due to defective design itself.Now the companies realized the need to improve quality company wide, improve everything that company did.

 Soon it was realized that defects were contributed by parts bought from vendors. In order to involve everybody within in the organization as well as with  the vendors the new concept was named total quality management. These concepts were initially introduced in Japan.

Quality management system

In order to ensure consistent quality output, through TQM, throughout the organization, International standards organization introduced three new standards, viz. ISO 9001, ISO 9002, and ISO 9003 forthe  implementation and certification of quality management systems. These standards were later combined into a single standard: ISO 9001 certification.Process approach was adopted for improvement of quality in every business activity. ISO 9001 Consultants continue to play an important role in the application of TQM, and successful implementation of ISO 9001.

 Two distinct approaches of TQM concept implementation emerged:

·         Continuous improvement approach  through quality circles (small group activity) at grass root level, and

·         Cross functional quality improvement teams (of experts), who try to improve quality through breakthrough solutions, which result in quantum jump in overall performance.

PDCA cycle:

TQM methodology involves four sequential stages, known as PDCA cycle:

In the planning stage, the team of people, identifies the problem to be solved and collectsfactsand data, and use the TQM tools such as 

·        

•       Brain storming
• ·         Fish bone  or Ishikawa diagram (Cause-effect relationship diagram)
• ·         Control charts
• ·         Check sheets
• ·         Pareto analysis
• ·         Histogram
• ·         Scatter chart
• ·         Process flowchart and
• ·         Stratification

Based on the root cause analysis done by using fishbone diagram, solutions are planned in this stage. Best solutions are determined and implemented in the Do stage.

During the Check stage, the team determines the measurements to decide the effectiveness of the solution implemented,and confirm the effectiveness.

In the Actstage team prepares the document of changes and the results, communicates to others in the organization so that solution can be adopted on companywide basis. Necessary training is given.  Based on the experience gained, next cycle of PDCA is initiated to ensure continuous improvement on a sustainable basis.

Aviation sector, among others, has reported successful implementation of TQM for improvements in maintenance.Benefits reportedinclude enhanced safety, reduced cycle time of fault diagnosis and repair activities as well as reduced down time.Latest quality improvement techniques  now being adopted include business process re-engineering(BPR), adoption of best practices(BP) and benchmarking(BM) as well as six sigma approach to fine tuning the processes.

Quality management system: why are there so many systems and ISO 9001 certifications and so few quality products and services?

You could recall your bitter experience, when you were made accountable for some challenging project, without authority to use the critical resources, available within the organization. There are situations when top management thinks that this project is a regulatory requirement, a necessary evil, which can in no way contribute to the bottom line. Sometimes top management as well as the senior staff members feel that Quality management system is forced on them by outsiders, and its outcome (success or failure) wont impact the organization. Some such issues may result in partial or complete failure of the QMS, resulting in poor quality of products and services.

Often a Government agency or a major client of yours insists on your implementing QMS, and getting it certified to ISO 9001 certification requirements. Third party audit as per ISO 9001 is able to reduce second party auditing costs.  Many of the certified vendors however, forget about QMS, once the certification is successful. They revisit it, only when the surveillance audit becomes due. QMS fails to make an impact on the business processes, as it is not used in planning the business operations of the company.

There are no doubt so many standards for the QMS, and there are regulatory requirements which add to burden of documentation and record keeping. International Standards Organization (ISO) is trying to adopt common structure for all of its standards, to reduce the duplication of documentation.

Quality management system partly successful

In some sectors of the economy however, QMS appears to be marginally successful in driving the realization of   better quality of products and services. Automobile part manufacturers, for example, who got their QMS certified, have been able to fulfil the requirements of some global customers. Second party audits by clients too have played a significant role, in maintaining product conformity.

Common causes of failure

There are some common reasons for the failure of Quality management systems. These are as follows:

1. Attitude of helplessness and indifference:

Lack of involvement of people results in an enforced system. People feel helpless and indifferent about new procedures and methods to be adopted for the success of the QMS processes. If people are involved in writing procedures, they are more likely to be enthusiastic about implementing the same.

2. Alignment of strategy and planning

Lack of alignment of business strategy, strategic plans and critical processes (process criteria) can result in a system that may not be successful in achieving results. Sustained efforts are needed in aligning and integrating the processes and their criteria, to drive improvement of quality for products and services. Planning must take into account the risks involved, due to unplanned changes in resources as well as the customer requirements.

3. Visibility of improvements

While improvement may be just trickling in, communication and visibility may be lacking in most cases. Excessive expectation can also harm the chances of success. We must show patience in looking for improvements. 

4. Visible leadership and support

Owners and top managers must be optimistic and willing to spare their time and energy to demonstrate visible commitment and support for ensuring success of the quality management system. They must motivate the process owners and employees to succeed in improving quality of products and services. Recognition of improvement effort too is important for driving the successful implementation of the system.

5 constraints of skills and other resources

Skill gap is an important bottleneck in many organizations that aspire to deliver world class products and services. Right HR policies and conducive working environment can ensure that right talent can be acquired. Performance management systems and people development plans must ensure that people keep upgrading critical skills and work in teams to ensure success for the organization through quality product and service offerings.

Management must invest in appropriate technology to be able to meet the changing   expectations of customers. Funds needed for QMS development and people development need to be made available.

Expertise in development of appropriate QMS is sometimes a constraint.  Selecting a competent ISO 9001 Consultant can help you overcome this bottleneck.

6. Clarity of Relationships and communication

Lack of clarity of area of responsibilities and overlaps sometimes cause nonconformities resulting in poor output quality. Effective communication by the top management must ensure that roles and responsibilities and interrelation ships are clearly understood and process interfaces don’t become ‘no man’s land’. Customer requirements and regulators expectations must be very clearly understood by each of the employees, as well as the vendor’s process owners. Interdependence and interaction of different processes and criteria of the processes must be clearly communicated.

7. Not being driven by customer

When the quality improvement is not driven by customer, the probability of success appears to be low. Customer involvement in quality improvement through QMS is a crucial requirement for visible quality improvement. When the voice of the customer is captured and used for improvement in product and service features, then the improvement efforts get aligned to customer requirements.

8. Audit which doesn’t look at the big picture

Auditors are trained to look at individual clauses of ISO 9001, but they fail to look at the big picture of quality of goods and services delivered by the company. Issues related to integration of network of processes and optimum balancing between customer expectations and needs of other interested parties such as shareholders and vendors can’t be easily audited. Auditor’s expertise in the business process and technology adopted by the company can sometimes add value to auditing process.

Safety Management System (SMS): The Safety Policy and Commitment Element

A safety management system is designed with the intent to serve as a framework for an organization, as a minimum, to meet its legal occupational safety and health obligations. A safety management system is only as good as its implementation and sustainable efforts.  A world class safety management system involves every level of the organization, instilling “the value of safety” within the workforce that reduces incidents and improves a reduction of risk. Furthermore, a world class safety management system provides evidence of continuous improvement. A business that embraces a safety management system, will have a story to tell and capturing continuous improvement within the elements of safety management system is a key factor of validating the safety management system.

As you know, within a safety management system, all parts are interrelated and affect each other. All elements within the safety management system are related to all other elements of the system. A flaw in one element will most likely impact all the other elements, and therefore the quality of the system as a whole.

This article will briefly focus on the Safety Policy and Commitment element. This particular element set the foundation of all the other elements for the one and only reason.  That reason is that the other elements must circle back to the safety policy and commitment. Remember, all activities within the safety management system are to reflect the safety policy and commitment set forth by the organization. 

SAFETY POLICY AND COMMITMENT

The organization must prepare an effective occupational safety policy that provides a clear direction for the organization tofollow in order to improve and continuously improve worker safety.  Once written, the policy and commitment will contribute to all other aspects of conducting day to day business within the organization.  The policy should provide a commitment to continuous improvement along with compliance to occupational safety law.  Defining expectations of customers’, stakeholders, employees and contractors should also be documented within the policy.

An example of a Safety Policy is:

• Safety and health in our company shall be a part of every operation.
• Safety is every employee's responsibility at all levels.
• We shall comply with local safety and health jurisdictional regulations.
• We shall maintain a safety and health management system conforming to the best practices within our specific industry.

An example of a Safety Commitment is:

The safety and health of every employee is a high priority. Management accepts responsibility for providing a safe and healthy working environment and employees, at all levels, shall take responsibility for performing work in accordance with established safety and health standards and practices. Safety and health will only be achieved through teamwork.  Everyone must join together in promoting safety and health and taking every reasonable measure to assure safe working conditions within our place of work.

In conclusion, operating on the principle of PLAN – DO – CHECK – ACT, a safety management system enables an organization to carefully examine what they do, define and implement safety improvements and continuously review and manage safety systems and processes.

PLAN - Plan the safety management system.

DO – Implement the safety management system.

CHECK - Evaluate the safety management system.

ACT - Improve the safety management system.

The PDCA activities should always, lead a path back to what is stated in the safety policy and commitment.   It will be a waste of time and energy to engage in activities that do not mirror the policy and commitment since those activities will not be based upon reducing hazards to an acceptable level of risk.

ISO 9001 Consultants And Auditors: How To Select Them

In many organizations ISO 9001 consultants play a significant role in the implementation of ISO 9001 and the subsequent certification audit. Their role is crucial because they can do the hand holding during your journey towards attaining business excellence through successful Implementation of the ISO 9001 quality management system. They enable faster learning and help you establish and implement a system that suits you very well. They help you choose the auditing firm(certification body), which is best suited to your business processes.

In order to attain successful ISO 9001 certification, it is essential to have a certification audit conducted in your premises. An independent auditing firm (registrar or the certification body) chosen by you will send qualified ISO 9001 auditors to visit your establishments for performing the external audit.  The firm will register your company for the audit and issue the certificate as soon as the audit process is completed successfully.

Sometimes there is confusion about the role of the external auditors and consultants. The consultants can’t audit and certify you, because they are meant to assist and coach you, whereas auditors must act as independent examiners. Consultants assist in planning and creating documentation so that a formal system is in place. If a QMS already exists; they will do the gap analysis to enable you to know what is missing, so that new procedures and other information can be added to ensure conformity. They train the internal auditors needed to conduct internal audit and provide awareness training to employees. They advise you on weaknesses in the system and preventive actions required. After the audit, they help you to resolve the NCs and other audit observations.

Selection of the ISO 9001 consultant

Consultant is selected on the basis of his or her past performance as well as the background. Trade bodies such as chambers of commerce, as well as professional bodies sometimes keep a list of approved   QMS consultants. Minimum requirement is that the consultant or his staff must have attended lead assessor training courses and transition courses and qualified themselves as lead assessors for the latest revision of the QMS standard. Websites of the consultants may give some idea about the industries they are able to guide and advice. Prior experience and knowledge of the applicable business processes could be a plus point.

 References from previous clients, as well as the results of previous projects in terms of time and cost incurred are considered. Often a small part of the project such as gap analysis is awarded initially. Milestone based fee is also one of the options. Consultants often provide a written proposal for a fee based on the size of the clients operation.

Selection of  the ISO 9001 Auditors (Registrars or Certification body)

 The ISO 9001 Registrar (certification body) is the independent entity that sends the auditors to conduct your certification audit. One must look for officially accredited registrars. The reputation of registrars should also be ascertained with the help of trade bodies or the professional bodies. The criteria for the selection of registrar can be finalized with help of your consultant.

Critical factors to be considered in the selection process include:

• accreditation and other credentials of certifying body or registrars (Every country has an accreditation body: ANSI-ASQ National accreditation Board in USA)
• scope of the accreditation: determine if the scope of accreditation certificate applies to  your business processes,
• references and global reputation/recognition
• fee for certification audit as well as subsequent surveillance audits
• their terms and conditions
• comfort level, flexibility to suit your time frame
• confidentiality and ethical issues
• how to tackle issues of interpretation of clauses of the applicable standard
• credentials and competence of  the auditors, who will be assigned to audit you.

Thus the selection of  a  competent consultant and  a reputed  certification body at a later stage, paves the way for successful certification of your company for ISO 90001.